Active Ingredient
Zinc Oxide….20.0%
Spf 50 Sunscreen Stick
FDA Label NDC 63645-178
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Oralabs for the product Spf 50 Sunscreen Stick (NDC 63645-178). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, keep out of reach of children, uses, warnings, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Sunscreen
Keep Out Of Reach Of Children
If swallowed; get medical help or contact a Poison Control Center right away.
Uses
Helps prevent sunburn. If used as directed with other sun protection measures (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
Warnings
For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs.
Directions
Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating. Immediately after towel drying. At least every 2 hours. Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun especially from 10 a.m. – 2 p.m. Wear long-sleeve shirts, pants, hats and sunglasses. Children under 6 months: Ask a doctor.
Inactive Ingredients
Aloe Extract, Behenyl Behenate, Shea Butter, Caprylic/Capric Triglyceride, Coconut Oil, Candelilla Wax, Sunflower Oil, Sunflower Wax, Polyhydroxystearic Acid, Castor Oil, Jojoba Oil, Squalane, Cocoa Butter, Tocopherol (Vitamin E).
* Please review the disclaimer below.
